MAUDE Adverse Event Report: LIVANOVA USA, INC. PROGRAMMING SOFTWARE

Model Number MODEL 3000

Device Problems Computer Software Problem (1112); High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2018

Event Type  malfunction  

Event Description

Clinic notes were received which reported that this patient was referred to neurosurgery due to a recent interrogation showing high lead impedance.The notes indicate that the patient may need both a lead revision and battery generator replacement.Additional information was received that the patient underwent surgery where only the generator was replaced and it was stated to be a prophylactic replacement.The lead was not replaced at this time.High impedance was not observed after surgery, and diagnostics were within normal limits.The explant facility historically has reported that they cannot release explanted devices without the patient signing a release.No other relevant information has been received to date.

Event Description

The explanted generator was received for product analysis.The generator underwent product analysis where it was found that the device performed according to functional specifications of the current automated final test.Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found.No further relevant information has been received to date.

Manufacturer Narrative

Suspect device software version: version 1.5.2.1.

Event Description

Additional information was received that high impedance was observed on the programming tablet m3000 software v1.5 when the patient's output currents were set >0ma.When the patient's output currents were set to 0ma normal lead impedance was observed.It was determined that the cause of this false high impedance message was a software error on m3000 v1.5.2.1 software; when system diagnostics were performed by the user with m3000 v1.5.2.1 software on m102/102r generators (normal mode output current >0 ma), normal mode diagnostics would actually be performed instead.The execution of normal diagnostics instead of system diagnostics is not apparent to the user, and the returned dcdc code was being compared against system diagnostic thresholds.It was determined that m102/102r system diagnostics functioned as expected when the generator was programmed to 0 ma and provided a true impedance value.No further relevant information has been received to date.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8216839
• MDR Text Key: 132055854
• Report Number: 1644487-2019-00004
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2006
• Device Model Number: MODEL 3000
• Device Lot Number: 010657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR